Usual Adult Dose for Erectile Dysfunction

INTRACAVERNOUS:
1 to 40 mcg intracavernous injection into the lateral penis given over 5 to 10 seconds

Maximum dose: 3 times per week, with at least 24 hours between each use

Comments:

• Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology: Initiate at 2.5 mcg; if there is partial response to initial dose, may increase to 5 mcg and then by increments of 5 to 10 mcg, depending upon erectile response, until the dose that produces an erection suitable for intercourse and not exceeding duration of 1 hour is reached; if there is no response to initial dose, may increase to 7.5 mcg and then by increments of 5 to 10 mcg.
• Erectile dysfunction of pure neurogenic etiology (spinal cord injury): Initiate at 1.25 mcg; may increase to 2.5 mcg, then 5 mcg, and then in 5 mcg increments until the dose that produces an erection suitable for intercourse and not exceeding duration of 1 hour is reached.
• The patient must remain in the physician's office following the first dose until complete detumescence occurs. If there is a response, the next dose may be given after a 1-day interval. If there is no response, the next higher dose may be given within 1 hour.

TRANSURETHRAL:
Initial dose: 125 or 250 mcg inserted into the urethra
Maximum dose: 2 systems per 24-hour period

Comments:

• Titrate to the lowest dose that elicits an erection suitable for intercourse.

Usual Pediatric Dose for Patent Ductus Arteriosus

Less than 12 Months:
Initial dose: 0.05 to 0.1 mcg/kg/min continuous IV infusion
Maintenance dose: 0.01 to 0.4 mcg/kg/min continuous IV infusion

Comments:

• The preferred route is continuous IV infusion into a large vein; may also be administered through an umbilical artery catheter placed at the ductal opening.
• Once a therapeutic response is achieved (increased partial oxygen pressure in patients with restricted pulmonary blood flow or increased systemic blood pressure and blood pH in patients with restricted systemic blood flow), reduce the infusion rate to the lowest dose that maintains the desired response.
• If response to initial dose is inadequate, dosage can be increased up to 0.4 mcg/kg/min. However, in general, higher infusion rates do not produce greater effects.

Use: Palliative, not definitive, therapy to temporarily maintain ductus arteriosus patency until corrective or palliative surgery can be performed in neonates with congenital heart defects who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, aortic arch interruption, aorta coarctation, or transposition of the great vessels with or without other defects.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• APNEA: Apnea is experienced by about 10% to 12% of neonates with congenital heart defects treated with the IV formulation of this drug. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and the IV formulation of this drug should be used where ventilatory assistance is immediately available.

Safety and efficacy have not been established in patients 1 year to less than 18 years for the IV formulation.
Safety and efficacy have not been established in patients younger than 18 years for the intracavernous and transurethral formulations.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice: Refer to manufacturer product information.

Storage requirements:

• IV: Store in a refrigerator at 2 to 8C (36 to 46F).
• Transurethral: Store unopened foil pouches in a refrigerator at 2 to 8C (36 to 46F). Do not expose to temperatures above 30C (86F); may be kept below 30C (86F) for up to 14 days prior to use.

Reconstitution/preparation techniques: Refer to manufacturer product information.

General:

• Better responses to the IV formulation are obtained in patients with low oxygen partial pressures (less than 40 mmHg) than in patients with high oxygen partial pressures (greater than 40 mmHg).

Monitoring:

• IV: Monitor arterial pressure intermittently by umbilical artery catheter, auscultation, or with a Doppler transducer. Measure blood oxygenation improvement in patients with restricted pulmonary blood flow. Measure improvement of systemic blood pressure and blood pH in patients with restricted systemic blood flow.
• Intracavernous: Examination of the penis at the start of therapy and regular intervals (e.g., 3 months) is recommended to identify any penile changes.

Patient advice:
Intracavernous:

• Instruct patients to report any unusual adverse effects such as new or increased penile pain, penile bending, and/or nodule formation in the penile shaft.
• Instruct the patient not to reuse or share needles or cartridges.

Intracavernous and Transurethral:

• Advise patients to seek immediate medical assistance for any erection lasting longer than 6 hours. If not treated immediately, penile tissue damage and permanent loss of potency may occur.
• Thoroughly instruct and train the patient in self-treatment technique prior to the patient beginning treatment at home.
• The dose established with the physician should not be changed by the patient without consulting the physician.
• Educate patients that use of this drug offers no protection from transmission of sexually transmitted or blood-borne diseases.
• Caution patients to avoid activities, such as driving or hazardous tasks, where injury could result if hypotension or syncope occurred.